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NCT Number: NCT05608746

Prehabilitation in Prostate Cancer Patients, TelePrehabTrial

Localized prostate cancer is commonly treated with radical prostatectomy (RP). Following surgery adverse effects such as urinary incontinence, erectile dysfunction associated with decreased quality of life and decreased physical function are common.

Traditionally, interventions to reduce these adverse effects are introduced postoperatively. However, a growing body of literature shows the benefit of interventions prior to surgery to enhance treatment success, known as prehabilitation.

Hence, the main purpose of this study is to develop and investigate the feasibility of prehabilitation using telehealth, to implement several interventions prior to elective RP.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Regional Hospital Goedstrup

Herning, 7400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male > 18 years
  • Diagnosed with prostate cancer and referred to robot assisted nerve sparring RP
  • Adequacy in written and spoken Danish
  • Cognitively well-functioning
  • Able to understand the study procedures and willing to provide signed informed consent

Exclusion criteria

  • Severe comorbidities that would prevent the patient from exercising, e.g. recent fractures, severe heart disease or neurological disorders.
  • No possibility to use a smartphone or tablet.

Treatment and study plan

Physical exercise

Other

Home-based individualized training, consisting of unsupervised aerobic exercise and resistance exercise, with moderate intensity. The pt. receives an exercise manual and exercise videos online, through an APP.

Pelvic floor exercise

Other

Patients will be assessed by a physiotherapist and instructed in a pelvic floor exercise program, accessed through the APP. Furthermore, the pt. is provided with general information about pelvic floor anatomy and muscle function.

Sexual Counseling

Other

Patients will be provided with 1 video-consultation with a clinical sexologist, during the prehabilitation period. The patients will be instructed in strategies to improve postoperative communication regarding, sex, realistic expectations, erectile dysfunction and the use of aids.

Nutritional Supplement

Dietary Supplement

Patients are systematically screened for malnutrition to assess the nutritional status. Patients are given recommendations with dietary advice online, through the APP. If the patient is at nutritional risk, the patient is provided with a nutritional supplement.

Stress management

Other

Patients are systematically screened for anxiety and depression. If patients are at risk of anxiety or depression, they are referred to a consultation with a nurse, who will provide information and strategies to handle the uncertainties they may experience.

Standard pre-surgical preparation and pt. information.

Other

One week preoperatively the usual regime for the presurgical preparation and information will be followed.

Primary outcomes

  1. Recruitment rate

    Time frame: 12 months

    Percentage of eligible patients who accepted to participate in the study. Recruitment rate is measured by dividing the number of patients consented by the number of patients screened.

  2. Protocol adherence, assessed by study-specific questionnaire

    Time frame: 12 months

    The pt. will every week register his adherence to the intervention protocol. The number of intervention components which were not fulfilled during the prehabilitation period will be counted, and the percentage of deviation will be calculated compared to the total number of intervention components.

  3. Number of participants who received the nutritional and mental health intervention.

    Time frame: 12 months

    Total number of participants who after the initial screening, needed the Nutritional and Mental Health intervention.

  4. Retention rate

    Time frame: 12 months

    Percentage of participants completing the full prehabilitation period, and full follow-up after the surgery. Retention rate is measured by dividing the number of patients completing the study with the number of patients consented.

Secondary outcomes

  1. 6-minute-walk-test (6MWT)

    Time frame: 12 months

    The 6MWT is a performance-based sub-maximal exercise test, used to assess aerobic capacity and endurance. The test covers the distance a person can walk on a 30-meters walkway, in the time of 6 minutes.

  2. 30 seconds sit-to-stand test (30STS)

    Time frame: 12 months

    30STS test is used to assess the leg strength and endurance. The test discovers how many times a person is able to rise up and sit down from a chair within 30 seconds.

  3. Grip strength test

    Time frame: 12 months

    Grip strength is a measure of muscular strength or the maximum force/tension generated by the forearm muscles.

  4. Self-reported physical activity

    Time frame: 12 months

    A questionnaire measuring physical activity consisting of three questions designed by The Swedish National Board of Health and Welfare (BHW).

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 12 months

    Hospital Anxiety and Depression Scale is a questionnaire used to identify anxiety disorders and depression among patients in nonpsychiatric hospital clinics. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.

  6. 12-Item short form Health Survey (SF-12)

    Time frame: 12 months

    The SF-12 is a short form of the 36-Item Short-form Health Survey (SF-36). It contains 12 items, and is a patient-reported survey of the patient's perception of health related quality of life, during the last 4 weeks.

  7. 5-Item International Index of Erectile Function (IIEF-5)

    Time frame: 12 months

    IIEF-5 is an abridged five-item version of the International Index of Erectile Function. It is a self-administered, multi-dimensional measure of erectile function.

  8. 24-hour Pad Weigh Test

    Time frame: 6, 24 and 50 weeks post surgery.

    The 24-hour Pad Weigh Test is used to investigate urinary incontinence.

  9. Nutritional Risk Screening

    Time frame: At baseline (4 weeks before the surgery).

    NRS-2002 is a validated tool for nutritional screening of patients between 18 and 90 years of age.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Gødstrup Hospital

Registry information

Official study title

Prehabilitation in Prostate Cancer Patients Undergoing Nerve Sparring Robot Assisted Radical Prostatectomy.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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